Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells
NCT ID: NCT04460755
Last Updated: 2020-07-08
Study Results
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Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2019-01-01
2020-09-30
Brief Summary
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The main objective in this study is to investigate the effectiveness of different brands of toothpastes with whitening effect and their performance (effect) on oral mucosa cells. As a measure of genotoxicity and cytotoxicity in cells, the number of micronuclei and other morphological changes of the nucleus are determined (micronucleus assay). Other specific objectives are to investigate the patient satisfaction with the characteristic of treatment such as final tooth color, color stability, length of treatment, comfort during treatment and overall participant satisfaction.
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Detailed Description
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Respondents are the students and employees of the School of the Medicine University of Split, Croatia. They will be divided in groups where different types of whitening toothpaste will be used. One group will use control non-whitening toothpaste. All respondents will use the same toothbrush during the research. Before using whitening toothpastes, all participants will use the same non-whitening toothpaste for one month. All participants will sign informed consent for participation in the research. Their participation will be voluntary. Respondents will be able to refuse to participate in the research without any consequences.
This study is approved by Ethic Committee of the School of Dental Medicine, Zagreb, Croatia (09.2018.) and Ethic Committee of the School of the Medicine University of Split, Croatia (12.2017). The study is randomized, prospective clinical trial.
The participants will be randomly selected for the whitening toothpaste groups and for the control non-whitening group. A sample of cells from the buccal mucosa area will be taken from each patient prior using the toothpastes under test, 30 and 60 days after the beginning and 30 days after using the toothpastes under test. Color assessment will be performed four times using the Vita Easyshade digital spectrophotometer: T0- before treatment (initial); T1- 30 days after the beginning; T2- 60 days after the beginning and T3- 90 days after the beginning of the study (i.e. 30 days after completing the treatment). The color reading will be performed in the middle third of the labial surface of the tooth, in the same environment and with the same light conditions. The measurement will be performed on all vital six anterior maxillary teeth, free of caries and restorations. Participant's satisfaction with the treatment and the toothpaste used will be assessed using the prepared questionnaires.
Participants will use toothpastes under test for two months. Toothpaste will be applied twice a day, in the morning and in the evening, for three minutes for 1g (app. 2 cm). During the experiment, the examinees will not use any toothpaste other than the one under test. Participants will use no other agents for oral hygiene.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Control group
A group of participants that will be using toothpaste without tooth whitening ingredients.
Control group
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 1
A group of participants that will be using urea peroxide whitening toothpastes.
Whitening toothpaste 1
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 2
A group of participants that will be using hydrogen peroxide whitening toothpastes.
Whitening toothpaste 2
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 3
A group of participants that will be using whitening toothpastes that contain abrasive ingredients.
Whitening toothpaste 3
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 4
A group of participants that will be using whitening toothpastes that contain enzymes as whitening ingredients.
Whitening toothpaste 4
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 5
A group of participants that will be using toothpastes that contain an activated charcoal.
Whitening toothpaste 5
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Interventions
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Control group
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 1
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 2
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 3
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 4
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Whitening toothpaste 5
A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study.
Eligibility Criteria
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Inclusion Criteria
* non smokers
* good oral and general health
* excellent oral hygiene
* vital six anterior maxillary teeth free of caries or restorations
* tooth shade A2 or darker
* no cervical lesions or prosthodontic treatments
* no periodontal disease
Exclusion Criteria
* breastfeeding women
* individuals with discolored teeth (tetracycline stain, fluorosis)
* tooth sensitivity
* history of allergy to any dental hygiene product
* individuals who had previously undergone any tooth whitening treatment
18 Years
65 Years
ALL
Yes
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Nada Zorica Vladislavic
Tooth Whitening Evaluation With Cytotoxic and Genotoxic Effect of Commercial Whitening Toothpastes on Oral Mucosal Cells
Locations
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School of the Medicine, University of Split
Split, , Croatia
Countries
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References
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Vladislavic NZ, Vladislavic J, Franic I, Tadin A. Cytotoxicity and genotoxicity of whitening toothpastes in buccal mucosal cells: a randomized controlled trial. Clin Oral Investig. 2023 Oct;27(10):6245-6259. doi: 10.1007/s00784-023-05241-6. Epub 2023 Sep 14.
Vladislavic NZ, Tadin A, Gavic L, Jerkovic D, Franic I, Verzak Z. In vivo evaluation of whitening toothpaste efficiency and patient treatment satisfaction: a randomized controlled trial. Clin Oral Investig. 2022 Jan;26(1):739-750. doi: 10.1007/s00784-021-04052-x. Epub 2021 Jul 10.
Other Identifiers
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2181-198-03-04-17-0063
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
05-PA-30-9/2018.
Identifier Type: -
Identifier Source: org_study_id
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